Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07472491 | A Phase 2/3 Study on the Efficacy and Safety of Mangaciclanol for Contrast-Enhanced MRI of CNS or Body in Adult Patients | PHASE2 | RECRUITING | 640 | — | — | Apr 1, 2026 | Nov 30, 2027 | May 18, 2026 | 5 | United States, Georgia +1 |
Overall diagnostic preference based on global matched pairs reads according to a 3-point scale that is derived from a 5-point scale (1 = greatly prefer mangaciclanol/prefer mangaciclanol, 0 = no preference, -1 = prefer gadobutrol/greatly prefer gadobutrol), as evaluated by 3 blinded independent readers.
Lesion visualization criteria (lesion border delineation, internal morphology and degree of lesion contrast enhancement) for paired (unenhanced plus mangaciclanol-enhanced) MRIs compared to unenhanced MRI based on the primary reads on a 4-point scale (1 = poor / none; 2 = moderate; 3 = good; 4 = excellent) for up to 3 of the most representative lesions.
| Arm | Type | Description |
|---|---|---|
| Phase 2 | ACTIVE_COMPARATOR | An initial dose of 0.1 mmol/kg mangaciclanol will be compared to the standard dose of gadobutrol (0.1 mmol/kg) in Cohort 1, in approximately 60 participants. A second cohort (Cohort 2) may be initiated based on the outcome of the analysis of Cohort 1. This cohort will include approximately 60 participants (higher or lower dose), or 30 participants (same dose), depending on the dose of mangaciclanol selected for further evaluation. |
| Phase 3 mangaciclanol-gadobutrol | ACTIVE_COMPARATOR | Participants with known or highly suspected lesions of CNS or body, randomized to receive treatment sequence mangaciclanol (V2) followed by gadobutrol (V4) |
| Phase 3 gadobutrol-mangaciclanol | ACTIVE_COMPARATOR | Participants with known or highly suspected lesions of CNS or body, randomized to receive treatment sequence gadobutrol (V2) followed by mangaciclanol (V4) |
| Name | Type | Description |
|---|---|---|
| Mangaciclanol, also known as GEH200486 Injection, 0.5 mmol/mL | DRUG | Single intravenous (IV) administration of Mangaciclanol (GEH200486 Injection, 0.5 mmol/mL) followed by a 20mL saline flush |
| MRI Scan | DIAGNOSTIC_TEST | MRI Scan starting prior to IMP administration and continuing for up to 60 minutes post IMP administration |
| Gadobutrol | DRUG | Single intravenous (IV) administration of Gadobutrol (0.1 mmol/kg) followed by a 20mL saline flush |
Inclusion Criteria: * The participant is of legal majority age, as defined by local laws and regulations at the time of signing the ICF. * The participant is able and willing to comply with study procedures as described in the protocol. * The participant has read, understood, signed and dated the I...